Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

NCT00481936 | Terminated Phase 1

• 1 other identifier: VB6-845-01-I
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin.

Conditions

Neoplasms, Glandular and Epithelial

Keywords

Neoplasms; Neoplasm, Epithelial; Neoplasm, Glandular

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion

  4 weeks

Secondary Outcomes (1)

• To evaluate the pharmacokinetics, immunogenicity and exploratory efficacy of VB6-845

  4 weeks

Study Arms (1)

Dose Escalating

EXPERIMENTAL

Patients will be treated with VB6-845 as a monotherapy IV infusion, once weekly in 4-week cycles. Patients will continue to receive treatment up until the treatment stopping criteria or patient withdrawal criteria are met. Dose escalation will begin at a dose level of 1.00 mg/kg. Doses will be escalated according to the modified Fibonacci design with dose multipliers of 2.00, 1.67, 1.50, 1.40, and 1.33.

Drug: VB6-845

Interventions

VB6-845 DRUG

Intravenous infusion once weekly for 4 weeks

Dose Escalating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease Characteristics:
• The patient must have locally advanced and/or metastatic solid tumour of epithelial origin for which standard therapy has failed or does not exist;
• The patient must have immunohistochemically-confirmed EpCAM positive disease;
• Patient Characteristics:
• The patient must be male or female 18 years of age or older;
• The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and life expectancy ≥ 12 weeks
• The patient must have adequate organ function, as defined by the protocol
• Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug;
• Other:
• The patient must be able to understand and willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
• The patient must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• The patient has had treatment with any investigational agent within 4 weeks, or treatment with radiation therapy to a visceral organ, immunotherapy, biological therapy, or chemotherapy within 2 weeks prior to the first dose of study medication
• The patient has known clinically significant brain metastases or leptomeningeal disease (baseline computed tomography \[CT\] or magnetic resonance imaging \[MRI\] of the brain is only required if there is clinical suspicion of central nervous system involvement);
• The patient has experienced a previous significant hypersensitivity reaction;
• The patient has known acquired immune deficiency disease or has active hepatitis virus C (HVC) or active hepatitis virus B (HVB);
• The patient is pregnant or breast feeding; female patients will be required to be surgically sterile, agree to use double barrier contraception, or commit to abstinence during the period of therapy; male patients will be required to be surgically sterile, use double barrier contraception, or commit to abstinence during the period of therapy
• The patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Sesen Bio, Inc.: lead

Study Sites (6)

Chemotherapy and Immunotherapy clinic Medulla

Tbilisi, Georgia

Location

Blokhin Cancer Research Centre, Department of Chemotherapy and Combined therapy

Moscow, Russia

Location

Blokhin Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy

Moscow, Russia

Location

Moscow City Oncology Hospital #62

Moscow, Russia

Location

Non state Institution of Ministry of Health "Central Clinical Hospital #2 named after N.A. Semashko" of Open-joint stock company "Russian Railways"

Moscow, Russia

Location

Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Neoplasms, Glandular and Epithelial; Neoplasms

Interventions

VB6-845 fusion protein

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type

Study Officials

• Wendy Cuthbert

  Sesen Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

GE (1); RU (5)